Mintz Levin - Health Law & Policy Matters

Medicaid Financing Reform: Per Capita Caps vs. Block Grants

In the coming weeks, it is highly likely that House Republicans will come forward with Medicaid financing reform proposals, such as block grant or a per capita cap proposal, or some combination of both. How should these…more
| Finance & Banking, Health

Medicaid Reform: It’s All About Paying Providers

Health care services cost money. Often times, a lot of money. This fundamental truism captures the challenge facing Congressional Republicans as they consider coverage of low income populations as part of their so-called…more
| Health

Fourth Circuit Permits DOJ to Reject an FCA Settlement, But Punts Decision on Statistical Sampling

In a closely watched False Claims Act (“FCA”) case, the Fourth Circuit Court of Appeals decided that the Department of Justice (“DOJ”) has an unreviewable right to object to a proposed settlement agreement between a relator and…more
| Civil Procedure, Government Contracting, Health

OIG Publishes Online Portfolio Highlighting its Body of Work on Drug Pricing and Reimbursement

For several years now, the public outcry over the issue of drug pricing and reimbursement has increased in frequency and fervor. At least one government agency wants you to know that it has been listening and wants to help…more
| Health, Science, Computers, & Technology

$5.5 Million HIPAA Settlement Underscores Importance of Audit Controls

On February 16, 2017, the HHS Office for Civil Rights (OCR) disclosed a $5.5 million settlement with Memorial Healthcare Systems (MHS) for HIPAA violations affecting the protected health information (PHI) of 115,143 individuals…more
| Consumer Protection, Health, Privacy, Science, Computers, & Technology

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible…more
| Communications & Media Law, Constitutional Law, Elections & Politics, Health, Science, Computers, & Technology

CMS’s Draft 2018 Call Letter: Minor Updates, but Largely a Continuation of Current Policies

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2018 Medicare Advantage and Part D Advance Notice and Draft Call Letter (“Draft Call Letter”). For the majority of the letter’s provisions, CMS…more
| Health

Another Court Agrees That A Difference Of Opinion On Medical Necessity Is Insufficient to Show Falsity Under the False Claims Act

Last month, the U.S. District Court for the District of Utah joined the AseraCare court and others in finding that a relator cannot successfully allege violations of the False Claims Act (“FCA”) based on a purported lack of…more
| Civil Procedure, Health

St. Jude Cybersecurity Vulnerability Extended to Provider-Owned Devices

Earlier this week, the U.S. Department of Homeland Security (DHS) updated a prior advisory revealing cybersecurity vulnerabilities in St. Jude Medical’s Merlin@home transmitter…more
| Consumer Protection, Health, Privacy, Science, Computers, & Technology

The Newly Updated Common Rule is Here – And On a Collision Course With the 21st Century Cures Act

On January 18th, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule updating regulations for the protection of human research subjects, the so-called “Common Rule.” The…more
| Health, Science, Computers, & Technology

Revised Draft 2018 Medicare Marketing Guidelines Open For Comment

Last week, CMS published the Revised Draft 2018 Medicare Marketing Guidelines and requested feedback from all interested parties. The draft includes many small changes to the Marketing Guidelines, including but not limited…more
| Health

Recent HIPAA Enforcement Actions

The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently announced the first ever settlement related to a Covered Entity’s untimely breach notification in violation of HIPAA. Presence Health, a…more
| Consumer Protection, Health, Privacy, Science, Computers, & Technology

Massachusetts Determination of Need Program – Final Regulations

The Massachusetts Department of Public Health (DPH) Determination of Need (DoN) Program has promulgated final DoN regulations (shown here compared against the draft revisions.) Approved by the Massachusetts Public Health…more
| Health

FDA’s Enforcement Priorities Likely to Change in 2017 and Other “Unknowable Knowns”

As we enter a new era in which executive agencies are headed by President Trump, we are also faced with many other transformative changes that will affect FDA-regulated entities in a significant and lasting way. This post will…more
| Elections & Politics, Health

Grassley Continues To Press CMS on Medicaid Drug Rebate Classifications: What Will Be the Fallout?

Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen. Although Mylan indicated that…more
| Health, Science, Computers, & Technology
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